Medical Device Classifications (Class I-IV)
If you know the JMDN (Japan Medical Device Nomenclature), you can also determine the class. If you know the class, you will also know the necessary regulatory procedures. Let's take a look at the classes here.
Under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Pharmaceuticals and Medical Devices Act), medical devices are classified into four classes according to the degree of risk to the human body in the event of a malfunction. Based on this classification, the procedures required for manufacturing and marketing (notification, certification, approval) are stipulated.
Japan's medical device classification is based on the GHTF (Global Harmonization Task Force). While it is generally similar among Japan, the US, and Europe, the US has a three-tier class system, and the EU has a four-tier system. Japan, which also uses a four-tier system, is considered close to the EU model.
Reference Materials
Class I: General Medical Devices
Class II: Controlled Medical Devices
Class III: Specially Controlled Medical Devices
Class IV: Specially Controlled Medical Devices
In cases there is no existing JMDN
For new medical devices and others for which no existing JMDN exists, the class is not known. In such cases, you can get a general idea by referring to the classification rules.
Please refer to Appendix 1, "Class Classification Rules," in the reference materials below to make an estimation.
Reference Materials
@K.Kamitani
Under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Pharmaceuticals and Medical Devices Act), medical devices are classified into four classes according to the degree of risk to the human body in the event of a malfunction. Based on this classification, the procedures required for manufacturing and marketing (notification, certification, approval) are stipulated.
Japan's medical device classification is based on the GHTF (Global Harmonization Task Force). While it is generally similar among Japan, the US, and Europe, the US has a three-tier class system, and the EU has a four-tier system. Japan, which also uses a four-tier system, is considered close to the EU model.
Reference Materials
- About Medical Device Class Classification, Approval, Certification, and Notification, Pharmaceuticals and Medical Devices Agency (PMDA)
- About Certification Standards, Approval Standards, and Review Guidelines for Medical Devices (PMDA)
Class I: General Medical Devices
- Definition:
- Devices for which the risk to the human body is considered extremely low, even in the event of a malfunction.
- Regulation:
- Marketing "notification" to the Pharmaceuticals and Medical Devices Agency (PMDA) is required. Approval or certification is not necessary.
- Examples:
- Surgical instruments: Scalpels, tweezers, forceps, scissors
- Diagnostic instruments: Stethoscopes, tongue depressors
- Sanitary materials: Adhesive bandages, gauze
- Others: X-ray film, many dental technician instruments
Class II: Controlled Medical Devices
- Definition:
- Devices for which the risk to the human body is considered relatively low in the event of a malfunction.
- Regulation:
- "Certification" by a third-party certification body registered under the law is required (some items may require approval).
- Examples:
- Imaging diagnostic systems: MRI systems, ultrasound diagnostic equipment, CT scanners
- Vital signs monitors: Electronic clinical thermometers, electronic blood pressure monitors, electrocardiographs
- Treatment instruments: Catheters for the digestive system, hypodermic needles
- Others: Home-use massage devices, hearing aids, electronic endoscopes
Class III: Specially Controlled Medical Devices
- Definition:
- Devices for which the risk to the human body is considered relatively high, as a malfunction could have a significant impact on life or health, thus requiring proper management.
- Regulation:
- Marketing "approval" by the Minister of Health, Labour and Welfare is required. Submission of data from clinical trials may be necessary for the approval application.
- Examples:
- Devices for assisting/substituting biological functions: Ventilators, dialyzers, infusion pumps
- Implantable products: Artificial bones, artificial joints, dental implants
- Treatment instruments: Vascular catheters, laser surgical units
- Others: Contact lenses that are in long-term contact with blood or tissue
Class IV: Specially Controlled Medical Devices
- Definition:
- Devices considered to have an extremely high risk to the human body and are highly invasive to the patient. Particularly careful management is required because, in the event of a side effect or functional failure, there is a risk of direct danger to life.
- Regulation:
- Similar to Class III, marketing "approval" by the Minister of Health, Labour and Welfare is required. The approval review is conducted with the utmost stringency.
- Examples:
- Cardiovascular implants: Cardiac pacemakers, implantable defibrillators, artificial heart valves, coronary stents
- Brain/nervous system devices: Deep brain stimulation systems
- Others: Heart-lung machines, products using materials derived from biological sources
In cases there is no existing JMDN
For new medical devices and others for which no existing JMDN exists, the class is not known. In such cases, you can get a general idea by referring to the classification rules.
Please refer to Appendix 1, "Class Classification Rules," in the reference materials below to make an estimation.
Reference Materials
@K.Kamitani